Mr. Robert Andrade reports

FENNEC PHARMACEUTICALS ANNOUNCES COMMERCIAL LAUNCH OF PEDMARQSI IN GERMANY

Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, has commercially launched Fennec Pharmaceuticals Inc.'s Pedmarqsi (sodium thiosulphate injection) in Germany.

In March, 2024, Fennec entered into an exclusive licensing agreement, under which Norgine will commercialize Pedmarqsi in Europe, Australia and New Zealand. Under the terms of the previously announced exclusive licensing agreement with Norgine, Fennec received approximately $43-million in an upfront payment and will receive up to approximately $230-million in additional commercial and regulatory milestone payments along with double-digit tiered royalties on net sales of Pedmarqsi starting in the mid-teens and growing to the mid-twenties.

"Until now, there have been no pharmacological interventions available to cancer patients in Germany to prevent ototoxicity, or permanent hearing loss, caused by treatment with cisplatin," said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. "We congratulate Norgine on making Pedmarqsi available to patients and health care providers in Germany and look forward to future launches in other major European markets."

The data from two open-label, randomized phase 3 trials, SIOPEL 6 (pivotal) and the Clinical Oncology Group (COG) Protocol ACCL0431, demonstrated an approximate 50-per-cent reduction in the occurrence of cisplatin-induced ototoxicity in patients treated with cisplatin and sodium thiosulphate versus those treated with cisplatin alone.

Pedmarqsi is the first and only approved therapy in the European Union and the United Kingdom for the prevention of ototoxicity, or hearing loss, induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic solid tumors. Pedmarqsi was granted marketing authorization by the European Commission in June, 2023, under the pediatric-use marketing authorization (PUMA), which includes eight years plus two years of data and market protection.

About cisplatin-induced ototoxicity

Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.

The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time. Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.

Pedmark (sodium thiosulphate injection)

Pedmark is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumours. Pedmark is also recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network as a preventive treatment option to reduce hearing loss associated with platinum-based chemotherapy in patients with localized, non-metastatic tumours. Pedmark is a unique formulation of sodium thiosulphate in single-dose, ready-to-use vials for intravenous use in pediatric patients. Pedmark is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen across two open- label, randomized phase 3 clinical studies -- the Children's Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

In the United States and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and suboptimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

Pedmark has been studied by co-operative groups in two phase 3 clinical studies of survival and reduction of ototoxicity -- COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumour, osteosarcoma, neuroblastoma, medulloblastoma and other solid tumours. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumours.

About Fennec Pharmaceuticals Inc.

Fennec Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of Pedmark to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, Pedmark received FDA approval in September, 2022, and European Commission approval in June, 2023, and United Kingdom approval in October, 2023, under the brand name Pedmarqsi. Pedmark has received orphan drug exclusivity in the United States and Pedmarqsi has received pediatric use marketing authorization in Europe, which includes eight years plus two years of data and market protection.

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